Progesterone: MPA oral 250mg-500mg qd for 3 months per cycle
Mirena®: levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle
GnRH agonist: GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle
Study summary
Primary end points:
This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.
Second end points:
To analyze the appearances of side-effects.
Eligibility
Sex
FEMALE
Min age
—
Max age
40 Years
Healthy volunteers
No
For Patients With Endometrial Cancer:
Inclusion Criteria:
* ≤40 years of age:
* Having a strong desire for fertility preservation;
* Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;
* Disease limited to the endometrium (stage 1A) on MRI;
* Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);
* Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.
Exclusion Criteria:
* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;
* Patients have lynch syndrome (LS);
* Patients have contraindications for pregnancy;
* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);
* Patients refuse to participate in clinical follow-up or sign the informed consent form.
For Patients With Endometrial atypical hyperplasia:
Inclusion Criteria:
* ≤ 40 years of age
* Having a strong desire for fertility preservation
* Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
* Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up
Exclusion Criteria:
* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
* Patients have contraindications for pregnancy
* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)
* Patients refuse to participate in clinical follow-up or sign the informed consent form.
Primary outcome measure(s)
Pathologic Response — 6-12 months Pathologic response to medicine treatment is categorized as complete response (CR), partial response (PR), no change (NC), and progressive disease (PD). CR is defined as the absence of any hyperplastic or cancerous lesion. PR is defined as the residual lesion with degeneration and atrophy of endometrial glands. NC is defined as residual lesion without degeneration or atrophy of endometrial glands. PD is defined as the appearance of endometrial cancer for EAH and grade 2 (G2) or 3 for EC.
Pregnancy Rate — 7-144 months The percentage of successful pregnancies in the CR patients.
Live Birth Rate — 16-144 months The percentage of successfully alive baby delivery in the pregnant patients.
Trial sites (1)
Facility
City
Region
Status
West China Second University Hospital
Chengdu
Sichuan
Recruiting
More West China Second University Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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